Maestro 1291H
by Nissha Medical Technologies Ltd
Maestro 1291H (M004N0011) is a Class II device made by Nissha Medical Technologies Ltd, cleared under FDA 510(k) K203494 on 23 Feb 2021 and listed in FDA GUDID since 27 Jan 2022 (UDI-DI 15060441919998), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number15060441919998 | Date27 Jan 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203494 | Date23 Feb 2021 | StatusActive |
Official records
- AccessGUDID record 15060441919998
- FDA 510(k) database K203494
Across registries
- FDA 510(k) K203494 decided 23 Feb 2021 Active
- FDA GUDID UDI-DI 15060441919998 listed 27 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K203494
- Listed FDA GUDID 15060441919998
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Maestro
- Generic name
- Electrosurgical return electrode, single-use
- Model / Ref / Catalog
- 1291H, M004N0011
- Primary DI / UDI-DI
- 15060441919998
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical return electrode, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electrosurgical return electrode, single-use.
- THERMOGARD 51-7410 by Conmed Corporation
- Tosap Plate 26189190 by Tolu Sadrneshinan Pars
- Olympus WA99516C by Olympus Winter & Ibe GmbH
- Olympus WA99514C by Olympus Winter & Ibe GmbH
- Bovie ESRE by Aspen Surgical Products, Inc.
- THERMOGARD PLUS ABC 7-383 by Conmed Corporation
- ERBE 20193-075 by Erbe Elektromedizin GmbH
- F7320W/V by FIAB S.p.A.
- RF-DGP-IS by ST. JUDE MEDICAL, INC.
- Disposable Patient Plate HPP221 by ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.